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Issue 45: 2021/Number One

Main features

Individual closed isolators for cell therapy

Didier Meyer

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Abstract

Cell Therapy originates as R & D but is regulated by cGMPs when the time comes for commercial application and delivery to patients. This article proposes personalized isolator technology using linked sterile individual isolators with multiple RTP connections to accommodate the various complex steps including centrifugation necessary to deliver properly re-engineered cells back to the patient.

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Cleanroom - known unknowns: 5. Separative devices and biological safety cabinets

Andrew Watson

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Abstract

Too often, Class II biological safety cabinets (BSCs) are used as the default separative device, particularly for small scale, specialised medicine manufacture. However, there are a range of other devices that are sometimes more suitable. When a Class II BSC is the only alternative, it is important that the right testing is performed to ensure that the separative device is operating to the level needed.

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Innovations

New hydrogen peroxide bio-decontamination method enhanced with ultrasonic wave energy

Koji Kawasaki and Gordon Farquharson

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Abstract

Bio-decontamination using hydrogen peroxide is expanding rapidly in the fields of pharmaceuticals and ATMPs (advanced therapy medicinal products). The current dominant bio-decontamination method uses flash evaporation of hydrogen peroxide, named ‘FE Method’ in this article, and is used as the reference method by Airex. The FE Method and alternative methods such as spraying fine aerosols require assistive mechanisms to aid diffusion of these agents into the target enclosed environment. In order to exploit the advantages of hydrogen peroxide as the agent of choice, with improved cycle times and repeatability, and overcoming the ‘fragility’ identified in the UK MHRA blog by Andrew Hopkins, the Airex Co. Ltd. has developed a new widely applicable bio-decontamination method based on dispersal of an ultra-fine aerosol inside the enclosed environment using an ultrasonic energy field to generate and disperse the aerosol without the need for dispersion fans or any other air movement assistance. Using this technique, called the ‘UD Method’, the amount of hydrogen peroxide used, compared to the traditional FE Method, is dramatically reduced, significant improvement to bio-decontamination cycle time is achieved, as well as reduction of adverse material surface impact on the biodecontamination strength. This new ‘UD Method’ can be applied to small pass boxes, larger enclosed environments such as isolators, and of course rooms.

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Regulatory reflections

Partnering with suppliers to get the best out of your Contamination Control Strategy (CCS)

David Keen

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Abstract

This article describes an approach to developing and implementing a Contamination Control Strategy (CCS) in the context of the evolving EU GMP Annex 1. The article recommends the appointment of a team with both internal and external expertise which can be provided by the supplier who will have considerable in-depth experience of the requirements for implementation. The team will assess what elements of a CCS are in place and identify the gaps, bearing risks in mind, to decide what is needed and then ensure that hard evidence and documentation are available for the regulators.

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Advertorial

Next generation integrated isolators for pharmacy production processes from Envair Technology

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